DeviceClearance

Product code QJP— Cardiovascular

Distal Access Catheter

Classification name
Catheter, Percutaneous, Neurovasculature
Device class
Class 2
Regulation
21 CFR 870.1250
Advisory panel
Cardiovascular
Total cleared
99
First cleared
Most recent

FDA classification definition

“To provide vascular access to the neurovasculature for interventional or diagnostic procedures”

— U.S. Food and Drug Administration, device classification record for product code QJP under 21 CFR 870.1250, via openFDA

Market context for product code QJP

FDA has cleared 99 devices under product code QJP between 2020 and 2026, filed by 43 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QJP

Adverse events under product code QJP

product code QJP
Death
43
Injury
233
Malfunction
1,010
Total
1,286

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code QJP

Data sourced from openFDA. This site is unofficial and independent of the FDA.